About This Role
This freelance role involves collaborating with an international clinical research team, focusing on managing complex scientific documentation and coordinating medical writing activities. It suits an experienced medical writer who can work independently and effectively with cross-functional teams and clients.
Responsibilities
- Act as Medical Writer on assigned projects and coordinate medical writing activities to ensure high-quality deliverables within agreed timelines
- Serve as the primary medical writing contact for clients, project managers, and cross-functional teams
- Provide medical writing guidance and review support to project team members, where required
- Prepare and review Clinical Study Protocols for early- and late-phase clinical trials, non-interventional studies, PASS, and other study types
- Prepare and review Participant Information Sheets and Informed Consent Forms for interventional and non-interventional studies
- Support study conduct and data-cleaning activities through the review of clinical data listings
- Prepare clinical sections of New Drug Applications (NDAs) and other regulatory submissions
- Prepare and review Investigator’s Brochures, Clinical Study Reports, manuscripts, posters, and other scientific or technical documents
- Contribute to study design documentation, proposals, and bid-related activities
- Provide scientific and medical writing expertise across different therapeutic areas
- Support the development of medical writing processes, templates, training materials, and best practices
- Act as a Subject Matter Expert and contribute to the continuous development of medical writing standards and knowledge
Requirements
- Graduate or postgraduate degree in Medical Sciences, Pharmaceutical Sciences, Life Sciences, Biostatistics, or another relevant scientific discipline
- At least 3 years of experience in clinical research
- At least 2 years of hands-on medical writing experience within clinical research or the pharmaceutical industry
- Strong knowledge of regulations, guidelines, and standards relevant to clinical and regulatory medical writing
- Good understanding of statistical methods commonly used in clinical trials and the ability to interpret clinical and statistical results
- Demonstrated ability to integrate, interpret, and summarize complex scientific information accurately and clearly
- Excellent scientific writing, editing, organizational, and communication skills
- Excellent command of written and spoken English
- Strong attention to detail and the ability to deliver high-quality work within demanding timelines
- Confidence working independently while collaborating effectively with multidisciplinary and international teams
